Clubfoot deformity is a relatively common birth defect affecting children from all backgrounds. Despite the frequency of the disease, affecting between one and five in every 1000 Caucasian live births over the years, there has been little consensus on how to treat congenital (diagnosed at birth) clubfoot. Clubfoot can be treated in several different ways. Surgery is one technique. Other techniques have no surgery involved and rely on manipulating the foot and leg to fix the deformity. One of these types of techniques is called the 'Ponseti Method'.
The Ponseti technique is comprised of a series of weekly casts for four to eight weeks. When the foot has been abduct 70 degrees, a complete percutaneous Achilles tenotomy is performed under general anesthetic. This is a less invasive procedure than open surgery. The leg is then placed in a cast for three weeks for the Achilles tendon to heal from the tenotomy. The children are then placed in bars and boots. These must be worn for 23 hours per day for the first three months after surgery, and then during the nighttime for the next two to four years.
The Ponseti technique has emerged as the most frequently performed technique for the treatment of congenital idiopathic clubfoot. Although widely utilized, there are few published studies documenting the success of the Ponseti method for treating congenital clubfoot compared to other methodologies.
The purpose of this study is first, to evaluate the short term effects of the Ponseti method. Second, the study will explore whether or not there was a difference in outcomes between patients seen in the clinic versus those seen in the private practice. And third, the study will create a database of clubfoot patients treated with the Ponseti method for long-term follow-up for function and quality of life assessments.
Who are Eligible?
Any patient diagnosed with idiopathic clubfoot being treated with Ponseti method is eligible. The initial treatment must begin while the child is between zero and six months of age and the patient must have at least 9 months of treatment for their clubfoot. Also, the patient must have the treatment received at the Pediatric Orthopaedic Division of Morgan Stanley Children's Hospital of New York or at the Vanderbilt Clinic Building of New York Presbyterian Hospital.
Study Procedures/Recruitment:
This study is both a retrospective study (using data from the past collected at the time of treatment) and a prospective (observational study involving patient evaluation for current clinical status and quality of life). By combining these two approaches we will be able to evaluate the long term quality of life issues associated with the Ponseti procedure, and to determine whether the treatment group (clinic or private) has any bearing on quality of outcome.
All retrospective patients were evaluated during the course of their treatment for congenital clubfoot using the Pirani clubfoot classification system. This retrospective data will be collected from a review of the subjects chart to determine the improvement in deformity after treatment. Subjects will be invited to return to the hospital for a physical evaluation to determine the current status of their clubfoot, and for their parents to complete questionnaires designed to assess their quality of life and child temperament. This will allow the investigators to make a final assessment as to the clinical status of the affected feet. For those parents who have already completed the CHQ and DSI, follow-up telephone interviews will be conducted to obtain child temperament scores. The Infant Characteristics Questionnaire (ICQ) will be used to obtain the child temperament scores. The Brace Compliance Questionnaire will be used to obtain the parent report compliance.
What are Quality of Life Outcomes Assessments?
The term "quality of life" refers to the physical, psychological and social domains of health. These health-related domains are seen as distinct areas that are influenced by a person's experiences, beliefs, expectations, and perceptions. Each of these domains can be measured in two ways: objectively and subjectively. Objective assessments of functioning or health status might come from the physician. Subjective assessments of functioning or health status might come from the patient or, in the case of measuring caregiver burden, the caregivers themselves. Although objective measures are important, subjective assessments are just as- if not more important. This is because expectations regarding health and the ability to cope with limitations and disability greatly affect a person's perception of health and satisfaction with life. Therefore, two people with the same health status, may have very different qualities of life.
Questions on the Child Health Questionnaire (CHQ) might be:
During the past 4 weeks, has your child been limited in the amount of time he/she could spend on school work or activities with friends due to EMOTIONAL difficulties or problems with his/her BEHAVIOR?
Or
During the past 4 weeks, how often has your child's health or behavior limited the type of activities you could do as a family?
What is Child Temperament?
Temperament is a set of in-born traits that organize the child's approach to the world. They are influential in the development of the child's distinct personality. These traits also determine how the child goes about learning about the world around him.
These traits appear to be relatively stable from birth. They are enduring characteristics that are actually never "good" or "bad.". For example some children are noisier than others. Some are more cuddly than others. Some have more regular sleep patterns that others. Questions on the child temperament questionnaire might be:
How easy or difficult is it for you to calm or soothe your baby when he/she is upset?
Or
How does your baby typically respond to new playthings?
What is a Disease Specific Instrument (DSI)?
One of the goals of this study is to develop the first ever Disease Specific Instrument (DSI) for this population. A Disease Specific Instrument is an instrument (for example, a questionnaire) that has been developed to measure the patient's perceptions of a specific disease or health problem. The advantage to developing a Disease Specific Instrument is that they provide an assessment of a particular dimension of health that is often more detailed than that provided by generic instruments that attempt to cover broader aspects of health. Many instruments, which include measures of physical functioning as well as psychological well-being, have been widely used. Therefore, there is a wide range of data available for comparing and interpreting results.
Questions from the DSI might be:
How satisfied are you with the appearance of your child's foot?
Or
Rate the amount of teasing your child has related to the clubfoot.
Purpose